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Substance-related DisordersWHAT-IF?NCT02907944

Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation

A study testing Implementation Facilitation in people with Substance-related Disorders, run by Yale University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics? Implementation Facilitation is an… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Substance-related Disorders
What is being tested?
Implementation Facilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,838 participants
Where
4 sitesUnited States
Study dates
Sep 2016to 30 Sep 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient inclusion criteria:
  • HIV-infected
  • Receiving HIV care in the index clinic
  • Age >18 years old
  • Meets criteria for lifetime or current tobacco, alcohol and/or opioid use disorder regardless of addiction treatment status
  • Able to provide verbal informed consent
Show all 12Show fewer
  • Staff inclusion criteria:
  • Employed at participating HIV clinic for at least 6 months
  • Able to provide verbal informed consent.
  • Payer/health insurance provider inclusion criteria:
  • Employed at an organization or agency that provides funding for medical services for HIV-infected individuals for at least 6 months.
  • Able to provide verbal informed consent.

Who cannot join

  • Unable to provide verbal informed consent

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Hartford Hospital's HIV Clinic

    Hartford, Connecticut, 06115

  • Haelen Center at Yale New Haven Hospital

    New Haven, Connecticut, 06511

  • Immunology Center at Miriam Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation (WHAT-IF?)

Tobacco, alcohol and opioid use disorders threaten the health of HIV-infected patients. What if evidence-based counseling and medication treatments for tobacco, alcohol and opioid use disorders (herein refered to as addiction treatments) were routinely provided in HIV clinics? Implementation Facilitation is an established strategy to increase the uptake of evidence-based treatments. Our goal is to evaluate the impact of Implementation Facilitation on the use of addiction treatments in four large HIV clinics.

The purpose of the WHAT-IF study is:

Read more

Aim 1. Among key stakeholders, to use quantitative and qualitative (mixed) methods to identify the site-specific evidence, context and facilitation-related barriers and facilitators to the integration of addiction treatments to help tailor an Implementation Facilitation for each clinic.

Aim 2. To evaluate the impact of Implementation Facilitation on:

2a: Organizational readiness to deliver addiction treatments 2b: Provider readiness to deliver addiction treatments 2c: Provision of addiction treatments 2d: Changes in organizational models of care used to deliver addiction treatments

Aim 3. To evaluate the impact of Implementation Facilitation on antiretroviral therapy receipt, HIV viral suppression, VACS Index, and retention in HIV care among patients eligible for addiction treatment.

Read the detailed description

The Working with HIV clinics to adopt Addiction Treatments using Implementation Facilitation (WHAT IF?) study will evaluate the impact of Implementation Facilitation on the adoption of addiction treatment services in four HIV clinics. We will use a stepped wedge design . The primary comparison is of the change that occurs from the pre-implementation period to two post-implementation periods, the initial six months (evaluation) and the following six months (maintenance). This proposal will consist of three main components in each of four clinics: 1) formative evaluation with key stakeholders at each site to guide and refine the Implementation Facilitation, 2) conduct of the Implementation Facilitation and 3) an evaluation of the impact of the Implementation Facilitation on organization and provider-level readiness, provision of addiction treatments, and HIV outcomes.

Being tested
Implementation Facilitation
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implementation FacilitationBehavioural

    Implementation Facilitation is an evidence-based strategy tailored to the specific needs of the clinic, designed to increase uptake of evidence based treatments for tobacco, alcohol and opioid use disorders. Will include provider education and academic detailing.

    • External Facilitator: Outside content expert who assists site
    • Local Champion: Site stakeholder who promotes change
    • Provider Education and Academic Detailing: Provision of unbiased peer education
    • Stakeholder Engagement: Aligning goals of implementation and those impacted
    • Tailor Program to Site: Addressing site specific needs based on Aim 1
    • Performance Monitoring and Feedback: Assess implementation of screening and treatment efforts and inform site of results
    • Formative Evaluation: Quant. and qual. determination of impact
    • Establish a Learning Collaborative: Shared learning opportunities tailored to stakeholders
    • Program Marketing: Increase attention to availability of on-site addiction treatment services
Study groups in NCT02907944
Study groupRoleWhat they receive
Usual Care- ControlNo interventionWe will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The first phase for all clinics is a control phase where clinic staff and patients engage in usual care. The time to implementation is randomly assigned. Each clinic is then followed prospectively to determine their outcome status.
Implementation FacilitationExperimentalWe will use a stepped wedge design to evaluate the effect of the Implementation Facilitation on the outcomes. The time to implementation in a stepped wedge design is randomly assigned. Clinics are then followed prospectively to determine their outcome status..
Receives: Behavioral: Implementation Facilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Provision of Addiction Treatments

    Study team will use the electronic health record (EHR) to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 6 month Intervention period.

    Measured: Baseline, 6 months

  2. Change in Provision of Addiction Treatments

    Study team will use the electronic medical record to identify prescriptions for each of the target medications in the surveillance period. Study team will use CPT codes to determine whether specific counseling therapies were provided. Patients diagnosed with Opioid Use Disorder and/or Alcohol Use Disorder and/or Tobacco Use Disorder were identified and then assessed in the EHR to determine if medication assisted therapy was provided by a provider during the 12 month Evaluation period.

    Measured: Baseline, 12 months

Secondary outcomes (12)
  1. Antiretroviral Therapy (ART) Receipt

    ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.

    Measured: 6 months

  2. Antiretroviral Therapy (ART) Receipt

    ART receipt will be defined as at least 180 days of three concurrent antiretroviral agents in the 6-month interval based on prescriptions in the electronic medical record.

    Measured: 12 months

  3. Viral Suppression

    Viral suppression, will be defined as HIV RNA <200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level "blips" that have no clinical significance.

    Measured: 6 months

  4. Viral Suppression

    Viral suppression, will be defined as HIV RNA <200 copies/mL at last test closest to the time of data extraction, consistent with Department of Health and Human Services (DHHS) guidelines. Although current limits of detection are lower, this cutoff allows for low-level "blips" that have no clinical significance.

    Measured: 12 months

  5. VACS Index

    The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.

    Measured: 6 months

  6. VACS Index

    The Veterans Aging Cohort Study Index (VACS Index) creates a score by summing pre-assigned points for age, routinely monitored indicators of HIV disease (CD4 count and HIV-1 RNA), and general indicators of organ system injury including hemoglobin, platelets, aspartate and alanine transaminase (AST and ALT), creatinine, and viral hepatitis C infection (HCV). This score is weighted to indicate increasing risk of all-cause mortality with increasing score. The score can be used to estimate risk of all-cause mortality using a conversion factor. The VACS Index will be evaluated based on most recent values at the time of data extraction. VACS Index score will be treated as a continuous variable. VACS Index: minimum value: 0; maximum value: 164- a higher score means a worse outcome.

    Measured: 12 months

  7. Retention in HIV Care

    Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.

    Measured: 6 months

  8. Retention in HIV Care

    Retention in HIV care, per DHHS guidelines uses a 24-month measurement period. It is defined as at least one HIV medical care visit in each 6-month period, with a minimum of 60 days between the first medical visit in the prior 6-month period and the last medical visit in the subsequent 6-month period. This measure has good agreement with the Institute of Medicine indicator for retention in care and is an independent predictor of mortality. We will evaluate whether patients have had at least 1 visit in the 6-month period prior to time of data extraction.

    Measured: 12 months

  9. Organizational Readiness

    Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.

    Measured: 6 months

  10. Organizational Readiness

    Investigators will use the ORCA to measure factors impacting the provision of addiction treatments. This 15-minute survey is based on the PARiHS framework and asks the respondent to rate local factors related to evidence, context and facilitation on a 5-point Likert scale from strongly disagree to strongly agree. Facilitation questions will be omitted from the pre-implementation assessment since this part of the intervention and will not have taken place. The score has a range from 1 to 5 where a higher score indicates higher readiness.

    Measured: 12 months

  11. Provider Readiness

    Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention. The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.

    Measured: 6 months

  12. Provider Readiness:

    Investigators will use change rulers, among appropriate providers, for each of the medications and counseling to assess readiness to provide each medication and counseling intervention.185 The change rulers will independently assess, on a 0-10 scale each provider's: 1) confidence to prescribe/provide the intervention, 2) readiness to prescribe/provide the intervention and 3) commitment to prescribe/provide the intervention. Presented is the score that indicates readiness to prescribe medication. The score has a range from 1 to 10 where a higher score indicates increased readiness.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
3,838 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02907944
Sponsor's protocol ID
HIC1509016500
Other IDs
R01DA041067
Acronym
WHAT-IF?
Status last verified
Apr 2023
First submitted
14 Sep 2016
Last updated
8 May 2023
Data monitoring committee
No
Individual data sharing
No

Publications

  • Edelman EJ, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Rebick G, Yager J, Morford K, Muvvala SB, Fiellin DA. Working with HIV clinics to adopt addiction treatment using implementation facilitation (WHAT-IF?): Rationale and design for a hybrid type 3 effectiveness-implementation study. Contemp Clin Trials. 2020 Nov;98:106156. doi: 10.1016/j.cct.2020.106156. Epub 2020 Sep 23.

    PubMed 32976995
  • Edelman EJ, Gan G, Dziura J, Esserman D, Morford KL, Porter E, Chan PA, Cornman DH, Oldfield BJ, Yager JE, Muvvala SB, Fiellin DA. Readiness to Provide Medications for Addiction Treatment in HIV Clinics: A Multisite Mixed-Methods Formative Evaluation. J Acquir Immune Defic Syndr. 2021 Jul 1;87(3):959-970. doi: 10.1097/QAI.0000000000002666.

    PubMed 33675619
  • Morford KL, Muvvala SB, Chan PA, Cornman DH, Doernberg M, Porter E, Virata M, Yager JE, Fiellin DA, Edelman EJ. Patients' perspectives of medications for addiction treatment in HIV clinics: A qualitative study. J Subst Abuse Treat. 2022 Aug;139:108767. doi: 10.1016/j.jsat.2022.108767. Epub 2022 Mar 18.

    PubMed 35341613
  • Edelman EJ, Gan G, Dziura J, Esserman D, Porter E, Becker WC, Chan PA, Cornman DH, Helfrich CD, Reynolds J, Yager JE, Morford KL, Muvvala SB, Fiellin DA. Effect of Implementation Facilitation to Promote Adoption of Medications for Addiction Treatment in US HIV Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236904. doi: 10.1001/jamanetworkopen.2022.36904.

    PubMed 36251291

Questions about this trial

What is this clinical trial studying?

A study testing Implementation Facilitation in people with Substance-related Disorders, run by Yale University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Provision of Addiction Treatments (time frame: Baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02907944, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.

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